Cervical Cancer: Clinical Trials
What are clinical trials?
Clinical trials are studies that test the safety and effectiveness of new drugs and other treatment options in a controlled, clinical setting. Many clinical trials are underway to help determine the value of the newest cancer therapies such as chemotherapy medications, radiation therapy, and vaccines.
Clinical trials are an important component for improving the treatment of cancer patients. In the U.S., all new cancer treatments must proceed through clinical trials before becoming commercially available.
Clinical trials and FDA - approval
There are two categories of clinical trials.
The first is a general category designed to evaluate new agents that have not yet been approved by the FDA. Prior to FDA approval, all substances must undergo clinical trials to determine their safety and effectiveness.
The second category is to evaluate agents that have already approved by the FDA for other purposes. These substances are being re-evaluated for possible treatment for other conditions such as cervical cancer.
Phases of clinical trials
Once an agent is approved for clinical trials, it must go through two to four phases for testing. Each phase is designed to gather specific information about risks, safety and effectiveness as compared to standard therapy.
Phase I trials are the most important. These usually involve a small number of patients whose previous standard therapy has failed. The primary goal of this phase is to determine if the agent is active in humans, what is the tolerated dosage, how the agent works in the body, and side effects related to different dosages.
Phase II trials are designed to determine how effective the treatment is in the dosage and schedules determined in phase I. Phase II has a higher number of participants than phase I. Therapies that are shown to be positive in phase II may then become standard treatment or be evaluated further for effectiveness in phase III trials.
Phase III trials compares new therapy with standard therapy in randomized and controlled tests. Phase III requires a large number of patients because age, sex, race and other factors could affect the results. Several doctors from different institutions usually take part in these trials.
Phase IV trials are for agents that have become part of standard therapy. This phase continues to evaluate and monitor the effectiveness and side effects of the treatment.
Where are clinical trials performed?
Clinical trials may be offered in large university hospitals, local community hospitals or by physicians. The location of the trial depends on the number of patients needed, resources, and interestsClinical trials and money
Most clinical trials are not free. Two costs associated with trials are patient care and research costs.
Patient care cost is the cost associated with providing medical care such as doctor’s visits, hospital stays, x-rays, and lab tests. These costs are usually covered by the patient’s insurance such as a third-party health plan, private insurance or Medicare.
Research costs are costs associated with clinical trial participation such as record keeping, nurse time, analysis of results and tests. These costs are usually covered by the sponsoring company.
Not all health insurance will pay for clinical trials. You will need to check with your health care provider to make sure it covers clinical trials before starting treatment. Medicare patients who wish to participate in clinical trials needs to discuss this with their doctor. Your doctor can recommend a trial that is partially covered by Medicare.
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This page was last updated:
June 12, 2006
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